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Xifaxan Side Effects Center
Pharmacy Editor: Charles Patrick Davis, MD, PhD
Xifaxan is a semi-synthetic antibiotic indicated for the treatment of patients ( ≥ 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli and for hepatic encephalopathy. Currently, Xifaxan has no FDA approved generic equivalent. Side effects may include nausea, vomiting, bloating, gas, abdominal pain, and people may feel they need to urgently defecate.
Xifaxan (rifaximin) tablets for oral administration are film-coated and contain 200 or 550 mg of rifaximin. Usual dosage is 200 mg three times a day for three days for diarrhea and 550mg twice a day for 3 days for hepatic encephalopathy. Serious side effects include C. difficile diarrhea and continued diarrhea due to organisms resistant to the drug. Caution is suggested when treating severe hepatic encephalopathy as systemic drug toxicity may develop. There are no adequate and well controlled studies of Xifaxan use in pregnancy; the drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known if the drug is present in breast milk. The safety and effectiveness of Xifaxan in pediatric patients with travelers' diarrhea less than 12 years of age have not been established.
Our Xifaxan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Xifaxan in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.
Less serious side effects are more likely, and may include:
- bloating, gas, stomach pain;
- feeling like you need to empty your bowel urgently;
- feeling like your bowel is not completely empty;
- nausea, vomiting, constipation;
- headache, dizziness;
- tired feeling; or
- swelling in your hands, feet, or torso.
Read the entire detailed patient monograph for Xifaxan (Rifaximin) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Xifaxan Overview - Patient Information: Side Effects
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Xifaxan (Rifaximin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xifaxan FDA Prescribing Information: Side Effects
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of XIFAXAN (rifaximin) 200 mg taken three times a day was evaluated in patients with travelers' diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN (rifaximin) . The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.
Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irrigation.
All adverse reactions for XIFAXAN (rifaximin) 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.)
Table 1: All Adverse Reactions With an Incidence ≥ 2% Among
Patients Receiving XIFAXAN (rifaximin) Tablets, 200 mg Three Times Daily, in Placebo-Controlled
|MedDRA Preferred Term||Number (%) of Patients|
Tablets, 600 mg/day
N = 320
N = 228
|Flatulence||36 (11%)||45 (20%)|
|Headache||31 (10%)||21 (9%)|
|Abdominal Pain NOS*||23 (7%)||23 (10%)|
|Rectal Tenesmus||23 (7%)||20 (9%)|
|Defecation Urgency||19 (6%)||21 (9%)|
|Nausea||17 (5%)||19 (8%)|
|Constipation||12 (4%)||8 (4%)|
|Pyrexia||10 (3%)||10 (4%)|
|Vomiting NOS||7 (2%)||4 (2%)|
|*NOS: Not otherwise specified|
The following adverse reactions, presented by body system, have also been reported in < 2% of patients taking XIFAXAN (rifaximin) in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers' diarrhea. The following includes adverse reactions regardless of causal relationship to drug exposure.
Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort
Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS
Injury and Poisoning: Sunburn
Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased
Metabolic and Nutritional Disorders: Anorexia, dehydration
Psychiatric Disorders: Insomnia
Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased
Vascular Disorders: Hot flashes NOS
The data described below reflect exposure to XIFAXAN (rifaximin) 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days). The safety of XIFAXAN (rifaximin) 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebocontrolled clinical trial (n = 140) and in a long term follow-up study (n = 280). The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN (rifaximin) 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease).
Table 2: Adverse Reactions Occurring in ≥ 5% of Patients
Receiving XIFAXAN (rifaximin) and at a Higher Incidence Than Placebo
|MedDRA Preferred Term||Number (%) of Patients|
Tablets 550 mg
N = 140
N = 159
|Edema peripheral||21 (15%)||13 (8%)|
|Nausea||20 (14%)||21 (13%)|
|Dizziness||18 (13%)||13 (8%)|
|Fatigue||17 (12%)||18 (11%)|
|Ascites||16 (11%)||15 (9%)|
|Muscle spasms||13 (9%)||11 (7%)|
|Pruritus||13 (9%)||10 (6%)|
|Abdominal pain||12 (9%)||13 (8%)|
|Abdominal distension||11 (8%)||12 (8%)|
|Anemia||11 (8%)||6 (4%)|
|Cough||10 (7%)||11 (7%)|
|Depression||10 (7%)||8 (5%)|
|Insomnia||10 (7%)||11 (7%)|
|Nasopharyngitis||10 (7%)||10 (6%)|
|Abdominal pain upper||9 (6%)||8 (5%)|
|Arthralgia||9 (6%)||4 (5%)|
|Back pain||9 (6%)||10 (6%)|
|Constipation||9 (6%)||10 (6%)|
|Dyspnea||9 (6%)||7 (4%)|
|Pyrexia||9 (6%)||5 (3%)|
|Rash||7 (5%)||6 (4%)|
The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking XIFAXAN (rifaximin) 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure.
Ear and Labyrinth Disorders: Vertigo
Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort
General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS
Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain
Investigations: Weight increased
Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity
Psychiatric Disorders: Confusional state
Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis
Vascular Disorders: Hypotension
The following adverse reactions have been identified during post approval use of XIFAXAN (rifaximin) . Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN (rifaximin) .
Infections and Infestations
Cases of C. difficile-associated colitis have been reported [see WARNINGS AND PRECAUTIONS].
Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.
Read the entire FDA prescribing information for Xifaxan (Rifaximin) »
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